FairEmbo Concept for Arterial Embolizations: In Vivo Feasibility and Safety Study with Suture-Based Microparticles Compa
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LABORATORY INVESTIGATION
EMBOLISATION (ARTERIAL)
FairEmbo Concept for Arterial Embolizations: In Vivo Feasibility and Safety Study with Suture-Based Microparticles Compared with Microspheres Mathieu Di Bisceglie1,2,3 • Jean-Francois Hak1,2,3 • Abdoulaye Dione Diop4 • Gloria Salazar5,6 • Pauline Brige2,3 • Julien Panneau1,2,3 • Farouk Tradi1,2,3,7 • Paul Habert1,2,3 • Jacques-Yves Campion3 • Abdoulaye Ndoye Diop8 • Gilles Soulez7 • Benjamin Guillet3,9,10 • Vincent Vidal1,2,3 Received: 25 July 2020 / Accepted: 3 October 2020 Ó Springer Science+Business Media, LLC, part of Springer Nature and the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) 2020
Abstract Purpose Microspheres are effective embolic agents, especially for the management of bleeding and oncologic lesions. The first FairEmbo study reported the effectiveness of embolization using suture fragments. The effectiveness and safety of arterial embolization with suture-based microparticles (SBM) were assessed in a swine model. Materials and Methods In this ethical-approved animal study, a polar artery in each kidney was embolized in four swine: one side with hand-cut non-absorbable SBM (Flexocrin 2Ò) and the contralateral side with EmbozeneÒ 900 for comparison. Swine were followed for 3 months & Mathieu Di Bisceglie [email protected] 1
Interventional Radiololy Section, Department of Medical Imaging, University Hospital Timone, APHM, Marseille, France
2
LiiE, Aix Marseille University, Marseille, France
3
CERIMED, Aix Marseille University, 27 Bd Jean Moulin 13005, Marseille, France
4
Diagnostic and Medical Imaging Center, Fann National University Hospital Center, 5035 Dakar, Senegal
5
Division of Interventional Radiology, Massachusetts General Hospital, Boston, MA, USA
6
Harvard Medical School, Boston, MA, USA
7
Department of Radiology, University Hospital Center of Montreal, Montreal, Canada
8
UFR 2S, Gaston Berger University, BP234, Saint Louis, Senegal
9
INSERM1263, INRA 1260, C2VN, Aix Marseille University, Marseille, France
10
Department of Radiopharmacy, APHM, Marseille, France
(M3) to evaluate the effectiveness and the safety of SBM. Follow-up protocol included clinical monitoring, computed tomography (CT) control and digital subtraction angiography (DSA), followed by histological analyses. The SBM confection parameters were evaluated by automatic microscopic sizer. RStudio software and Mann–Whitney test (significance at P \ 0.05) were used for statistics. Results The average size of SBM was 1002 lm (SD = 258). All targets were effectively embolized by SBM with an angiogram defect estimated at 45.6% (95% CI [35.9–55.2]), compared to 40.5% (95% CI [30.6–55.5]) for EmbozeneÒ group (P = 0.342). The average duration of SBM embolization procedure was significantly increased compared to EmbozeneÒ embolization (1202 s versus 222 s, P = 0.029). There were no statistical differences in M3 DSA and CT for SBM and EmbozeneÒ, with persistence of partial arterial occlusion and atrophic embolized area. No postop
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